Case Alert: Hernia Mesh
Over the last decade, hundreds of thousands of people have been injured nationwide by hernia mesh products. Although medical device companies have tried to keep these injuries quiet, the word has finally gotten out. Hernia meshes are dangerous and lawsuits are now being filed nationwide. If you or someone you know has been injured by a hernia mesh product, the attorneys at Burke Harvey are ready to help.
What is Hernia Mesh?
Hernia mesh is a medical device used to provide additional support to weakened or damaged tissue. The majority of surgical mesh devices currently available for use are constructed from synthetic materials. Many hernia mesh products contain a type of plastic known as polypropylene, the same material that is used to make many types of pelvic mesh and bladder slings. Out-of-date literature and scientific studies found that polypropylene was safe for hernia repair, only causing severe complications when used as a pelvic mesh. While working on pelvic mesh and bladder sling litigations, it became apparent to our attorneys that there was a correlation to complications from those patients who had received hernia mesh as well.
Why Does Hernia Mesh Cause So Many Complications?
What causes the complications can vary depending on the hernia mesh product. Over time, surgeons began to insert and secure hernia mesh via laparoscopic procedures. When a hernia is repaired in this way, some surgeons insert the mesh deeper into the abdominal cavity, causing the mesh to come in contact with the bowel and resulting in severe complications. In addition, many hernia mesh products have been found to cause damage to the surface of any organ they are touching.
How Have Surgeons Been Convinced to Use Mesh?
The manufacturers of hernia mesh products funded studies to demonstrate that there was a lower rate of hernia recurrence when hernia mesh was utilized. These studies were lacking in many ways, such as the length of time that patients were monitored after mesh implantation and what were considered “normal complications.” Often hernia mesh complications occur 10 to 15 years after implantation once the mesh erodes into their bowels. These later complications are not captured by the studies.
Differences in Mesh Placement
There are three different ways to implant in a hernia repair.
Overlay: the hernia mesh is placed between the skin/subcutaneous tissue and rectus abdominis. Mesh is easiest to remove when it is placed in the overlay position.
Inlay: The hernia mesh is placed between layers of the rectus abdominis.
Underlay: The hernia mesh is placed between the rectus abdominis and the peritoneum. The hernia mesh has a higher chance of attaching to the patient’s underlying organs when placed in the underlay position.
What Are the Life-Threatening Complications from Hernia Mesh?
Unlike sutures, which have relatively few and minor possible complications, hernia mesh failure frequently causes life-threatening complications, such as:
- erosion into the bowel
- multiple additional surgeries
- weeks of hospitalization
- partial bowel removal
- systemic infection
- dental infections or teeth rotting out
Even if there is a slightly reduced rate of hernia recurrence when mesh is used, it doesn’t justify the risk of life-threatening complications.
Injuries and Complications
Hernia mesh is used to repair both ventral and inguinal hernias. Various injuries and complications can occur depending on what part of the body the mesh is placed. A coated hernia mesh is also more likely to cause injuries such as infections than a non-coated hernia mesh. Complications that can occur include:
- Infection, including sepsis. An infected hernia mesh almost always requires removal.
- Adhesions frequently form when ventral hernias are repaired with a coated mesh, connecting the bowel to the hernia mesh.
- Bowel obstruction caused by the formation of adhesions, evidenced by a change in bowel habits or the inability to defecate.
- Abdominal pain: a sign of possible adhesions, a bowel obstruction or nerve damage.
- Rashes: commonly observed with hernia meshes such as the C-Qur V-Patch and Ventralex ST.
- Leg, Groin and Testicular Pain: Inguinal hernias repaired with mesh frequently lead to the development of debilitating lower body pain.
- Pain with Sex (dyspareunia): This is caused from the mesh used to repair an inguinal hernia attaching to the spermatic cord.
- Testicle Removal: If the mesh erodes far enough into the spermatic cord, it is often necessary to remove the testicle with the hernia mesh.
- Diarrhea: Can be an early symptom of the mesh attaching to the bowel.
- Constipation: Can be a sign of bowel obstruction. You should consult a doctor if your constipation persists for several days.
- Nausea: can be an additional sign of adhesions to the bowel and stomach.
- Seroma is a fluid capsule surrounding the mesh. Seromas can be present with and without infection.
- A fistula is an abnormal tunnel between two structures and has been observed many fistula connecting to the bowel, which are associated with infections.
- Dental Problems: A large number of mesh failures have been associate with a loss of teeth after a hernia mesh infection.
- Autoimmune Disorders: An alarming number of people have develop autoimmune disorders after being implanted with a pelvic or hernia mesh.
- Neurological Changes: Unexplained neurological changes on a CT scan after implantation
- Severe Headaches: Typically a sign of a larger problem, such as an infection.
- Fever: Associated with both an autoimmune response to the mesh and infection.
- Renal Failure: Observed in those implanted with large coated meshes. The coatings are absorbable and put a lot of stress on the kidneys.
- Liver Abnormalities: Documented in those implanted with coated hernia meshes. The liver is responsible for cleansing the body.
- Joint Aches and Pain: caused by systemic inflammation due to infection and an autoimmune reaction to the mesh.
- Abnormal Sweating: can be related to an autoimmune response or an infection.
- Meshoma: the migration, contracture or bunching up of an artificial mesh.
Current Hernia Mesh Lawsuits and Investigations
There are many different hernia mesh products available, many of which are manufactured by different medical device companies. The strengths and weaknesses of a hernia mesh lawsuit are in part determined by which company manufactured the hernia mesh and the exact mesh that was utilized. Below is a list of products we have seen a large number of complaints about:
C-Qur: The C-Qur is a composite hernia mesh coated with fish oil that came to market in 2006. Initially marketed by Atrium Medical Corporation, The Getinge Group acquired Atrium in 2011 and now manufacturers the C-Qur hernia mesh. The FDA has issued several warning letters and even sued Atrium Medical Corporation for violations. Recently, the FDA shut down one of Atrium’s facilities that manufactured the C-Qur hernia mesh. Atrium has only issued recalls on the C-Qur’s packaging, not on the actual C-Que hernia mesh itself.
C-Qur hernia mesh is associated with life-threatening systemic infections and severe allergic reactions. Removing the C-Qur is extremely difficult and can result in further injury. The C-Qur hernia mesh remains on the market, even as lawsuits continue to mount.
Physiomesh: Made by Ethicon, a subsidiary of Johnson & Johnson, this product was removed from the market in May 2016 by the company. The FDA website does not contain any information on the Physiomesh recall and Ethicon continues to deny there was a recall, but they do admit they withdrew the product from the market.
3DMax: This product is a bare (non-coated) polypropylene mesh used to repair inguinal (groin) hernias. Many have experience severe, debilitating lower extremity pain after being implanted with the Bard 3DMax mesh. The 3DMax mesh can attach to the spermatic cord in men, causing severe testicle pain. Once the mesh is attached to the spermatic cord, there is a risk of losing the testicle when removing the mesh.
PerFix Plug: Like the 3DMax, the PerFix plug is another bare polypropylene mesh used to repair inguinal hernias. The PerFix Plug has been observed to come unwoven over time, causing many to experience severe pain and difficulty exercising, along with the possibility of losing a testicle.
Ventralex ST: This mesh is coated in a polyglycolic acid and is causing severe allergic reactions. The Ventralex ST is manufactured by Davol, a subsidiary of CR Bard.
Hernia Mesh Lawyer in Birmingham
If you or someone you know used hernia mesh products and developed injuries and complications, the attorneys at Burke Harvey are ready to help you understand your legal rights.